# K151382: Patient Contoured Implant-PEEK (PCI-PEEK)

- Pathway: 510(k) (Traditional)
- Applicant: KLS Martin L.P.
- Decided: Nov 9, 2015 after 171 days
- Product code: GXN (Plate, Cranioplasty, Preformed, Non-Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904111 (1990). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072707: Patient Contoured Mesh-Peek (PCM-P), KLS-Martin L.P. (2007) Summary page 4.

## Most influential descendants
- K252573: KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE (2025), 0 descendants of its own
- K214109: PEEK Patient Specific Cranial/Craniofacial Implant (PSCI) (2022), 0 descendants of its own

## Indications for use
The Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.

Source page: https://510kreport.com/device/K151382
Methodology: https://510kreport.com/methodology